BILL NUMBER: AB 1731 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 9, 2012
INTRODUCED BY Assembly Member Block
FEBRUARY 16, 2012
An act to amend Sections 124977 and 125001 of
add Article 6.6 (commencing with Section 124121) to Chapter 3 of
Part 2 of Division 106 of the Health and Safety Code, relating
to public health.
LEGISLATIVE COUNSEL'S DIGEST
AB 1731, as amended, Block. Newborn screening program.
program: critical congenital heart disease.
Existing law provides for the Newborn and Infant Hearing
Screening, Tracking, and Intervention program, under which general
acute care hospitals with licensed perinatal services, as specified,
are required to administer to newborns a hearing screening test for
the identification of hearing loss, as prescribed, using protocols
developed by the State Department of Health Care Services, or its
designee.
This bill would require general acute care hospitals with licensed
perinatal services to offer to parents of a newborn, prior to
discharge, a pulse oximetry test for the identification of critical
congenital heart disease (CCHD), using protocols approved by the
department or its designee. This bill would require the department to
phase in implementation of a comprehensive CCHD screening program on
or after July 1, 2013, and require 100% participation by these
hospitals by December 31, 2016. This bill would require these
hospitals to develop a CCHD screening program, as prescribed.
Existing law requires the State Department of Public Health to
establish a program for the development, provision, and evaluation of
genetic disease testing. Existing law establishes the continuously
appropriated Genetic Disease Testing Fund (GDTF), consisting of fees
paid for newborn screening and other tests. Existing law states the
intent of the Legislature that all costs of the genetic disease
testing program be fully supported by fees paid for newborn screening
tests, which are deposited in the GDTF. Existing law authorizes
moneys in the GDTF to be used for the expansion of the Genetic
Disease Branch Screening Information System, as specified, to include
cystic fibrosis, biotinidase, and severe combined immunodeficiency.
Existing law exempts the expansion of contracts for this purpose from
provisions of the Public Contract Code that establish standards for
contracts and requires the Department of General Services to approve
these contracts. Existing law also exempts the expansion of contracts
for this purpose from standards for personal services contracts and
from provisions that give the California Technology Agency authority
over the application of information technology for state agencies.
This bill would require the department to expand statewide
screening of newborns as soon as possible to include pulse oximetry
screening for critical congenital heart disease, and would exempt the
expansion of contracts for this purpose from provisions that
establish standards for contracts, require the Department of General
Services to approve contracts, and give the California Technology
Agency authority over information technology projects, as described
above.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Article 6.6 (commencing with Section
124121) is added to Chapter 3 of Part 2 of Division 106 of the
Health and Safety Code , to read:
Article 6.6. Newborn Critical Congenital Heart Disease
Screening Program
124121. The Legislature finds and declares the following:
(a) Congenital heart disease affects about seven to nine of every
1,000 live births in the United States and is the most common cause
of death in the first year of life, with defects accounting for 3
percent of all infant deaths and more than 40 percent of all deaths
due to congenital malformations.
(b) Critical congenital heart disease (CCHD) is a group of defects
that cause severe and life-threatening symptoms and require
intervention within the first days or first year of life.
(c) Current methods for detecting CCHD generally include prenatal
ultrasound screening and careful and repeated clinical examinations.
(d) CCHD is often missed during the routine clinical exam that
generally is scheduled prior to a newborn's discharge, and many cases
of CCHD are also missed during discharge and postdischarge clinical
exams.
(e) Fetal ultrasound screening programs improve detection of major
congenital heart defects; however, prenatal diagnosis alone picks up
less than half of all cases.
(f) Pulse oximetry is a noninvasive test that estimates the
percentage of hemoglobin in blood that is saturated with oxygen.
(g) Virtually all hospitals, including small hospitals, frequently
use pulse oximetry as a standard of care in their newborn nurseries.
(h) Many newborn lives could potentially be saved by earlier
detection and treatment of CCHD if hospitals were required to perform
this simple, noninvasive newborn screening method.
124122. For purposes of this article, "CCHD" means critical
congenital heart disease.
124123. (a) (1) A general acute care hospital with licensed
perinatal services shall offer to parents of a newborn, prior to
discharge, a pulse oximetry test for the identification of CCHD,
using protocols approved by the State Department of Health Care
Services or its designee. The department shall begin phasing in
implementation of a comprehensive CCHD screening program by general
acute care hospitals with licensed perinatal services on or after
July 1, 2013, and a 100-percent participation rate shall be achieved
by 2016.
(2) A hospital described in paragraph (1) shall be responsible for
developing a screening program that provides competent CCHD
screening, utilizes appropriate staff and equipment for administering
the testing, completes the testing prior to the newborn's discharge
from a newborn nursery unit, refers infants with abnormal screening
results for appropriate care, maintains and reports data as required
by the department, and provides physician and family-parent
education.
(b) A pulse oximetry test provided for pursuant to subdivision (a)
shall be performed by a licensed physician, licensed registered
nurse, or an appropriately trained individual who is supervised in
the performance of the test by a licensed health care professional.
(c) This section shall not apply to a newborn whose parent or
guardian objects to the test on the grounds that the test is in
violation of his or her beliefs.
SECTION 1. The Legislature finds and declares
the following:
(a) Congenital heart disease affects about seven to nine of every,
1000 live births in the United States and is the most common cause
of death in the first year of life, with defects accounting for 3
percent of all infant deaths and more than 40 percent of all deaths
due to congenital malformations.
(b) Critical congenital heart disease (CCHD) is a group of defects
that cause severe and life-threatening symptoms and require
intervention within the first days or first year of life.
(c) Current methods for detecting CCHD generally include prenatal
ultrasound screening, and careful and repeated clinical examinations.
(d) CCHD is often missed during the routine clinical exam that
generally is scheduled prior to a newborn's discharge, and many cases
of CCHD are also missed during discharge and postdischarge clinical
exams.
(e) Fetal ultrasound screening programs improve detection of major
congenital heart defects; however, prenatal diagnosis alone picks up
less than half of all cases.
(f) Pulse oximetry is a noninvasive test that estimates the
percentage of hemoglobin in blood that is saturated with oxygen.
(g) Virtually all hospitals, including small hospitals, frequently
use pulse oximetry as a standard of care in their newborn nurseries.
(h) Many newborn lives could potentially be saved by earlier
detection and treatment of CCHD if hospitals were required to perform
this simple, noninvasive newborn screening method.
SEC. 2. Section 124977 of the Health and Safety
Code is amended to read:
124977. (a) It is the intent of the Legislature that, unless
otherwise specified, the genetic disease testing program carried out
pursuant to this chapter be fully supported from fees collected for
services provided by the program.
(b) (1) The department shall charge a fee to all payers for any
tests or activities performed pursuant to this chapter. The amount of
the fee shall be established by regulation and periodically adjusted
by the director in order to meet the costs of this chapter.
Notwithstanding any other provision of law, any fees charged for
prenatal screening and followup services provided to persons enrolled
in the Medi-Cal program, health care service plan enrollees, or
persons covered by health insurance policies, shall be paid in full
and deposited in the Genetic Disease Testing Fund or the Birth
Defects Monitoring Fund consistent with this section, subject to all
terms and conditions of each enrollee's or insured's health care
service plan or insurance coverage, whichever is applicable,
including, but not limited to, copayments and deductibles applicable
to these services, and only if these copayments, deductibles, or
limitations are disclosed to the subscriber or enrollee pursuant to
the disclosure provisions of Section 1363.
(2) The department shall expeditiously undertake all steps
necessary to implement the fee collection process, including
personnel, contracts, and data processing, so as to initiate the fee
collection process at the earliest opportunity.
(3) Effective for services provided on and after July 1, 2002, the
department shall charge a fee to the hospital of birth, or, for
births not occurring in a hospital, to families of the newborn, for
newborn screening and followup services. The hospital of birth and
families of newborns born outside the hospital shall make payment in
full to the Genetic Disease Testing Fund. The department shall not
charge or bill Medi-Cal beneficiaries for services provided under
this chapter.
(4) (A) The department shall charge a fee for prenatal screening
to support the pregnancy blood sample storage, testing, and research
activities of the Birth Defects Monitoring Program.
(B) The prenatal screening fee for activities of the Birth Defects
Monitoring Program shall be ten dollars ($10).
(5) The department shall set guidelines for invoicing, charging,
and collecting from approved researchers the amount necessary to
cover all expenses associated with research application requests made
under this section, data linkage, retrieval, data processing, data
entry, reinventory, and shipping of blood samples or their components
and related data management.
(6) The only funds from the Genetic Disease Testing Fund that may
be used for the purpose of supporting the pregnancy blood sample
storage, testing, and research activities of the Birth Defects
Monitoring Program are those prenatal screening fees assessed and
collected prior to the creation of the Birth Defects Monitoring
Program Fund specifically to support those Birth Defects Monitoring
Program activities.
(7) The Birth Defects Monitoring Program Fund is hereby created as
a special fund in the State Treasury. Fee revenues that are
collected pursuant to paragraph (4) shall be deposited into the fund
and shall be available upon appropriation by the Legislature to
support the pregnancy blood sample storage, testing, and research
activities of the Birth Defects Monitoring Program. Notwithstanding
Section 16305.7 of the Government Code, interest earned on funds in
the Birth Defects Monitoring Program Fund shall be deposited as
revenue into the fund to support the Birth Defects Monitoring
Program.
(c) (1) The Legislature finds that timely implementation of
changes in genetic screening programs and continuous maintenance of
quality statewide services requires expeditious regulatory and
administrative procedures to obtain the most cost-effective
electronic data processing, hardware, software services, testing
equipment, and testing and followup services.
(2) The expenditure of funds from the Genetic Disease Testing Fund
for these purposes shall not be subject to Section 12102 of, and
Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of,
the Public Contract Code, or to Division 25.2 (commencing with
Section 38070). The department shall provide the Department of
Finance with documentation that equipment and services have been
obtained at the lowest cost consistent with technical requirements
for a comprehensive high-quality program.
(3) The expenditure of funds from the Genetic Disease Testing Fund
for implementation of the Tandem Mass Spectrometry screening for
fatty acid oxidation, amino acid, and organic acid disorders, and
screening for congenital adrenal hyperplasia may be implemented
through the amendment of the Genetic Disease Branch Screening
Information System contracts and shall not be subject to Chapter 3
(commencing with Section 12100) of Part 2 of Division 2 of the Public
Contract Code, Article 4 (commencing with Section 19130) of Chapter
5 of Part 2 of Division 5 of Title 2 of the Government Code, and any
policies, procedures, regulations or manuals authorized by those
laws.
(4) The expenditure of funds from the Genetic Disease Testing Fund
for the expansion of the Genetic Disease Branch Screening
Information System to include cystic fibrosis, biotinidase, severe
combined immunodeficiency (SCID), and critical congenital heart
disease may be implemented through the amendment of the Genetic
Disease Branch Screening Information System contracts, and shall not
be subject to Chapter 2 (commencing with Section 10290) or Chapter 3
(commencing with Section 12100) of Part 2 of Division 2 of the Public
Contract Code, Article 4 (commencing with Section 19130) of Chapter
5 of Part 2 of Division 5 of Title 2 of the Government Code, or
Sections 4800 to 5180, inclusive, of the State Administrative Manual
as they relate to approval of information technology projects or
approval of increases in the duration or costs of information
technology projects. This paragraph shall apply to the design,
development, and implementation of the expansion, and to the
maintenance and operation of the Genetic Disease Branch Screening
Information System, including change requests, once the expansion is
implemented.
(d) (1) The department may adopt emergency regulations to
implement and make specific this chapter in accordance with Chapter
3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title
2 of the Government Code. For the purposes of the Administrative
Procedure Act, the adoption of regulations shall be deemed an
emergency and necessary for the immediate preservation of the public
peace, health and safety, or general welfare. Notwithstanding Chapter
3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title
2 of the Government Code, these emergency regulations shall not be
subject to the review and approval of the Office of Administrative
Law. Notwithstanding Sections 11346.1 and 11349.6 of the Government
Code, the department shall submit these regulations directly to the
Secretary of State for filing. The regulations shall become effective
immediately upon filing by the Secretary of State. Regulations shall
be subject to public hearing within 120 days of filing with the
Secretary of State and shall comply with Sections 11346.8 and 11346.9
of the Government Code or shall be repealed.
(2) The Office of Administrative Law shall provide for the
printing and publication of these regulations in the California Code
of Regulations. Notwithstanding Chapter 3.5 (commencing with Section
11340) of Part 1 of Division 3 of Title 2 of the Government Code, the
regulations adopted pursuant to this chapter shall not be repealed
by the Office of Administrative Law and shall remain in effect until
revised or repealed by the department.
(3) The Legislature finds and declares that the health and safety
of California newborns is in part dependent on an effective and
adequately staffed genetic disease program, the cost of which shall
be supported by the fees generated by the program.
SEC. 3. Section 125001 of the Health and Safety
Code is amended to read:
125001. (a) The department shall establish a program for the
development, provision, and evaluation of genetic disease testing,
and may provide laboratory testing facilities or make grants to,
contract with, or make payments to, any laboratory that it deems
qualified and cost-effective to conduct testing or with any metabolic
specialty clinic to provide necessary treatment with qualified
specialists. The program shall provide genetic screening and followup
services for persons who have the screening.
(b) The department shall expand statewide screening of newborns to
include tandem mass spectrometry screening for fatty acid oxidation,
amino acid, and organic acid disorders and congenital adrenal
hyperplasia as soon as possible. The department shall provide
information with respect to these disorders and available testing
resources to all women receiving prenatal care and to all women
admitted to a hospital for delivery. If the department is unable to
provide this statewide screening by August 1, 2005, the department
shall temporarily obtain these testing services through a competitive
bid process from one or more public or private laboratories that
meet the department's requirements for testing, quality assurance,
and reporting. If the department determines that contracting for
these services is more cost-effective, and meets the other
requirements of this chapter, than purchasing the tandem mass
spectrometry equipment themselves, the department shall contract with
one or more public or private laboratories.
(c) The department shall expand statewide screening of newborns to
include screening for severe combined immunodeficiency (SCID) as
soon as possible. In implementing the SCID screening test, the
department shall also screen for other T-cell lymphopenias that are
detectable as a result of screening for SCID, insofar as it does not
require additional costs or equipment beyond that needed to test for
SCID.
(d) The department shall expand statewide screening of newborns as
soon as possible to include pulse oximetry screening, when feasible
between 24 and 48 hours after birth, for critical congenital heart
disease.